510(k) K260551 ยท GGW Test, Time, Partial Thromboplastin
HemosIL Factor V Leiden (APC Resistance V)
| Applicant | Instrumentation Laboratory (IL) Co., Bedford MA, US |
| Decision | Substantially Equivalent, Mar 20, 2026 |
| Received | Feb 18, 2026 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K260551
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.